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Trial record 3 of 27 for:    lymphoma proton

Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02404818
First received: March 20, 2015
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.

Condition Intervention
Hodgkin's Lymphoma
Procedure: Cardiac Magnetic Resonance Imaging
Procedure: Echocardiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Cardiac Abnormalities As Measured By Cardiac MRI [ Time Frame: Day 1 ]
  • Cardiac Abnormalities As Measured By Echocardiogram [ Time Frame: Day 1 ]

Estimated Enrollment: 5
Study Start Date: April 2015
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Survivors of Hodgkin's lymphoma
Cardiac Magnetic Resonance Imaging and Echocardiogram
Procedure: Cardiac Magnetic Resonance Imaging
A cardiac MRI will be performed.
Procedure: Echocardiogram
An echocardiogram will be performed for the following information: M-mode, two-dimensional, Doppler blood flow measurements, and longitudinal strain and strain rate imaging

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.
Criteria

Inclusion Criteria:

  • Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
  • Patient must be ≥ 18 years at time of consent.

Exclusion Criteria:

  • Pregnant women at time of Cardiac MRI
  • Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices)
  • Glomerular filtration rate (GFR) < 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02404818

Locations
United States, Florida
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Health Proton Therapy Institute
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02404818     History of Changes
Other Study ID Numbers: UFPTI-1431-HL02
Study First Received: March 20, 2015
Last Updated: March 3, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Radiation
Cardiac
Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2017